American Association for Clinical Chemistry
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November 2011 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles


HHS Proposes Direct Patient Access to Lab Results

The Department of Health and Human Services (HHS) has proposed new rules that would expand the rights of patients and specifically allow them the right to gain access to test reports directly from labs. The new rules would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives.

To make such direct access possible, the proposed rules tackle the interplay among the Clinical Laboratory Improvement Amendments of 1988 (CLIA) rules, state laws governing direct disclosure to patients of their laboratory test results, and the Federal Privacy Rule, which currently defers to CLIA’s disclosure provisions and which preempts contrary state laws on privacy and disclosure of personal health information. Under existing CLIA regulations, a laboratory may release patient test results directly to the patient only if the ordering provider expressly authorizes the laboratory to do so at the time the test is ordered, or state law expressly allows for it.

Although the current privacy rule does generally require healthcare providers to give individuals access to their health information on request, when it comes to test results, it defers to CLIA. As a result, in 26 states without laws authorizing direct disclosure of test results to patients and 13 states that expressly prohibit it, patients cannot directly access their lab records. The new proposed rule amends both CLIA and the Federal Privacy Rule to fix this conflict.

The proposed rule is available from the Federal Registeronline. Comments will be accepted through November 12, with final rules expected before the end of the year.

Final RAC Rule Released

The Department of Health and Human Services (HHS) released its final rule for the Medicaid Recovery Audit Program, a new breed of anti-fraud initiative where private-sector firms—called Recovery Audit Contractors (RAC)—audit provider billing practices and get to keep 10% of over- or underpayments they discover. Created by the Affordable Care Act, the Medicaid Recovery Audit Program can now be used by states comprehensively for both Medicare and Medicaid claims.

Over the next five years, HHS hopes to squeeze $2.1 billion out of the program, of which $900 million will be returned to states. This comes as the Medicare Recovery Audit program completes its second year of being used nationally. The Medicare Recovery Audit Program is on pace to increase the amount of Medicare overpayments recovered by nearly 800%, from roughly $75 million in 2010 to nearly $670 million in 2011.

In addition, the final rule makes several other changes to the program: states may exclude Medicaid managed care claims from review by RACs; states must make referrals of suspected fraud and abuse to the appropriate agencies; a RAC should not audit claims that are older than 3 years from the date of the claim, unless it receives approval from the state; and, if a provider appeals a Medicaid RAC overpayment determination and the determination is reversed, the RAC must return the money in a reasonable timeframe.

The proposed rule is available from the Federal Registeronline.

CDC Issues New Proposed Guidelines for Organ Transplantation

Draft guidelines from the Centers for Disease Control and Prevention on organ transplants call for more thorough donor screening and more advanced organ testing to help protect patients from infections. The draft recommends adding hepatitis B and hepatitis C to the list of organisms to be screened, and that nucleic acid amplification or the “most sensitive test available” be used for screening. The guidelines focus only on solid organs and vessel conduits, and not other tissues because the Food and Drug Administration has implemented more comprehensive regulations for tissue and semen donors.

Titled Draft 2011 Public Health Service Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation, the document is available online. Comments will be accepted until November 21.